ADJUSTABLE GASTRIC BANDING SYSTEM
FDA premarket approval P000008/S033 · decided 2015-05-27
Approval details
- PMA number
- P000008
- Supplement
- S033
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- ADJUSTABLE GASTRIC BANDING SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2015-01-29
- Decision date
- 2015-05-27
- Days to decision
- 118 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL FOR A POST-APPROVAL STUDY PROTOCOL.
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